ISO 15189:2012

Management Requirements
ISO 15189 Standard
• Sets out the criteria for medical laboratories
wishing to demonstrate that they are:
•Technically competent to perform the examinations
•Operate an effective quality system, and
•Are able to generate technically valid test results which
can be reproduced.
• The standard will form the basis for the
accreditation of competence of laboratories by
most accreditation bodies.
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Contents of ISO 15189
• The standard is divided into 5 major sections
1. Scope
2. Normative references
3. Terms and definitions
4. Management requirements
5. Technical requirements
• Sections 1,2 and 3 are for guidance only and are not
auditable
• The ‘meat’ of 15189 resides in the last 2 sections
• 4- Management requirements
• 5- Technical Requirements
• and laboratories have to effectively satisfy these
requirements.
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Management Requirements of ISO
15189:2012
1. Organisation and management responsibility
2. Quality management system
3. Document control
4. Service agreements
5. Examination by referral laboratories
6. External services and supplies
7. Advisory Services
8. Resolution of complaints
9. Identification and Control of Non-conformities
10. Corrective action
11. Preventive action
12. Continual Improvement
13. Control of records
14. Evaluation and audits
15. Management review
4.1: Organisation and Management
Responsibility
4.1.1.2. The laboratory must be legally responsible.
• There should be evidence that it is operating within the confines of the
laws of the jurisdiction (National and regional laws)
• This can be in terms of
 Registration of the laboratory facility with oversight bodies
 Licensure to operate medical laboratory testing
 Licensure of personnel conducting the testing with relevant
oversight bodies
 Other national laws in terms of employment of personnel.
4.1.1.3. Ethical Conduct
• There should be arrangements to ensure:
1. There is no involvement in activities that diminish confidence
in laboratory’s competence, impartiality, judgment or
operational integrity.
 Fabrication, falsification, or misrepresentation of data
2. Management and personnel are free from any undue
commercial, financial or other pressures.
3. Potential conflict in competing interests are openly and
appropriately declared.
4. Treatment of human samples according to relevant legal
requirements.
 Patient samples to be analyzed only for tests requested
 Use of patient samples for research projects
 Transportation, handling and disposal of samples - IPC guidelines
5. Confidentiality of information is maintained.
4.1.1.4 Duties of the laboratory Director
• Revise lab director job description to fulfil new requirements

• Duties can be delegated but ultimate responsibility lies with the Lab
Director.

• Each of the mentioned duty should be found in the job description of

the personnel that have been delegated the responsibility.

• Discuss for each a) through o)

4.1.2: Management responsibility
• 4.1.2.1 Management Commitment: The top management shall
provide evidence of its commitment to the implementation and
maintenance of the QMS.
• a) to h) Discuss for each
• i) Ensure availability of adequate resources
• Financial resources (Approved Lab budget)
• Human resources
• Provision of adequate resources can be evaluated by looking for
stoppage of testing due to:
• lack of reagents (inadequate budget)
• Equipment breakdown and no urgent repair and service
• Financing for PT , equipment calibration etc.
4.1.2 Management responsibility
• 4.1.2.2Needs of Users: Lab management should ensure that
lab services meet the needs of the laboratory users.
• Some of the proactive measures to satisfy users are:
1. Conduct meetings with lab users,
2. Periodic review of requests – 4.14.2
3. Customer satisfaction surveys
4. Monitoring and evaluation of user feedback
4.1.2.3 Quality Policy
• In basic terms, the quality policy is a single statement of commitment
from the highest-level members of the organization that articulates their
visions of how they will meet their business objectives and satisfy their
customers.
• The Quality Policy should :
a) Be appropriate to the purpose of the organization
b) Include statements of commitment to GLP, examinations that are fit
for intended use, compliance to ISO 15189, and continual
improvement.
c) Provide a framework for establishing and reviewing objectives
d) Be communicated and understood within the organization –
management’s responsibility
e) Be reviewed for continuing suitability
4.1.2.4 Quality Objectives and planning
• The lab should establish quality objectives at relevant functions and
levels within the organisation.
• The objectives should be “SMART” but most of all they should be
measurable.
• Provide framework for monitoring
• Management to involve staff in establishing objectives – staff
suggestions to be taken to MRM
• The quality plans should comprise of
• Activity
• Responsible person
• Target timeline
• Status.
4.1.2.5 Responsibility, authority and
interrelationships
• Responsibilities, authorities and interrelationships should be clearly
documented and communicated within the organization.
• These can be done in the job descriptions and the organization chart.
• Each laboratory function/section/department should have a
responsible person.
• Deputies for key management and technical functions should be
appointed.
• In smaller laboratories one person may do several functions however,
their job descriptions should clearly indicated that.
4.1.2.6 Communication
• There should be appropriate communication processes , both internal
and external communication regarding the effectiveness of the quality
management system.
• Communication can be in the form of
• Meetings (minutes of meetings)
• Memoranda (ensure the target audience are aware)
• Laboratory reports (on the comments section)
• Telephone
• Communication with clients when the laboratory can not perform tests for
whatever reason or when there are some critical results.
4.1.2.7 Quality Manager
• The quality manager/however named should be
appointed:
1. QO reports to Lab director
2. Important functions of QO should be:
1. managing the QMS .
2. Planning and conducting internal audits
3. Reporting on the performance on QMS.
4. promotion of awareness of users’ needs and requirements throughout
the laboratory
5. NR for accrediting body – SADCAS TR 03, section 3
4.2 Quality Management System
• The laboratory shall
• Determine the processes needed for the quality management
system and ensure their application throughout the
laboratory.
• Determine the sequence and interaction of these processes.
• Determine criteria and methods needed to ensure that both the
operation and control of these processes are effective
• Ensure availability of resources
• Monitor and evaluate these processes
• Implement actions to achieve planned results and continual
improvement
4.2.2.1 Documentation requirements

QPS Are statement of intent based on the

Policies requirements of the standard clauses
Policy
manual
Are the means of putting the intent
Objectives into practice
and Plans

Are detailed step by step instructions

Procedures of carrying out activities

Records: Are the evidence that

Records + External procedures are carried out.
Documents External documents include
regulation documents, books , stds
Ensure that there is consistency in the application of the documentation structure throughout
4.2.2.2 Quality Manual
• The quality manual should include:
• The quality policy statement or make reference to it.
• Scope of the QMS
• Management structure of the organization and its place in the parent
organization
• Description of roles and responsibilities of laboratory
management
• Documentation structure.
• System policies and reference to supporting documentation
• All laboratory staff shall have access to and be instructed on the use
and application of the quality manual and referenced documents.
4.3 Document Control
• Main purpose is to ensure that only current, authorised documents are
available on points of use.
• All documents required by the QMS should be controlled whether
internal/ external documents.
• Documents can be kept in soft copy or hard copy systems.
• A procedure for document control should be in place which should cover
at least: document creation, approval, change, review/revision and
destruction.
• All documents in use should be approved for use.
• All documents should be identified by
• Title
• A unique identifier
• The date of the current edition/version/revision
• Page numbering e.g. Page 1 of 5
• Authority for issue (records on authored, reviewed by)
Document Control

• Changes to documents are to be identified. This can be achieved by

using table of summary of changes or highlighting the changes.
• Documents should be periodically reviewed and updated at a
frequency that ensures that they remain fit for purpose (at most 2
years)
• Consider review when there is change of standards
• Obsolete controlled documents are dated and marked as
obsolete (Stamp/watermark)
• At least one copy of the old controlled document is retained
4.4 Service Agreements –
Review of contracts in 2007 edition
• The laboratory should have a procedure for establishing and review of
service agreements.
• contract/agreement include – individual test requests, institution
seeking diagnostic service, research projects
• All these should consider
• Tests requested
• Request forms to be used
• Sample requirements e.g. volumes
• Examination methods
• Format of Report
4.4 Service Agreements
• The following conditions shall be met when the lab enters into an
agreement:
 The requirements of the users and of the laboratory shall be defined,
documented and understood (in SCM)
 Lab shall have resources and skilled personnel to
carry out the examinations
 Examination procedures should be appropriate to meet customers needs
 Inform customers of any deviation to the agreement

 Referred work should be identified

4.5: Examination by Referral Laboratories

• Referral laboratories are required in situations when the laboratory

may fail to test patient samples.
• The referral laboratory may be asked to provide emergency testing
services when a short term interruption of service at the referring
laboratory is caused by:
 instrument breakdown,
 unavailability of personnel
 sudden increase in volume,
 or any other unscheduled or unanticipated situation.
Evaluation and Selection of Referral laboratories
• The laboratory should evaluate and select referral laboratories.
• Procedure should state criteria for selection of reference laboratories.
• These are some of the criteria for the selection of the referral
laboratories:
 Accreditation to ISO 15189 or equivalent standard
 Performance in EQA and having good results
 Conducting an on-site assessment or getting reports of the previous
assessments by external bodies
 Sending known samples to the referral laboratories and performing very
good
4.5.1 Selecting and evaluating referral
laboratories and consultants
• The register of referral laboratories, should be available and the actual
evidence of evaluation as well

• Records for all requests and results of all samples referred are kept
for a pre-defined retention period.
4.5.2: Provision of Examination Results
• The referring laboratory is responsible for ensuring that examination
results of the referral laboratory are provided to the person making the
request.

• If the referring laboratory prepares the patient report, the report

should include all essential elements of the results reported by the
referral laboratory without alteration
4.6: External Services and supplies
• The laboratory should have a procedure for the selection and
purchasing of external services and supplies

• Organisations supplying the following should be evaluated and evidence

there-off available:
 Laboratory reagents and consumables

 Equipment service and calibration

 Laboratory equipment
Criteria for Evaluation of Suppliers

• The lab should have the criteria for evaluation of suppliers

and here are some:
 Cost of the reagents/consumables or services

 Performance in terms of lead time

 Quality of goods supplied ( can be monitored overtime)

 Appropriate storage facilities by the suppliers site

 Implementing quality management systems

4.6 External services and supplies
• A list of selected approved suppliers of equipment, reagents
and consumables shall be maintained.
• The laboratory shall monitor the performance of suppliers to
ensure that purchased products consistently meet the stated
requirements.
• Records of performance should be evaluated
4.7 Advisory Services
• The laboratory shall establish arrangements for communication
with users on the following:
 Advising on choice of examination and use of the services.

 Advising on individual cases.

 Professional judgments on interpretation of results

 Promoting the effective utilisation of lab services

 Consulting on scientific and logistic matters such as instances of failure of

sample(s) to meet acceptance criteria
4.8 Resolution of complaints
• Laboratory shall have a documented procedure for the management of
complaints or other feedback received from the
 clinicians,
 Patients
 Laboratory staff
 Other parties
• The laboratory is actively receiving complaints and that they are dealing
with them as per their procedure.
• Also ensure that the complainant is contacted if possible and that they are
satisfied with the action taken.
• Ensure there is no conflict of interest when resolving internal complaints
 4.9 Identification and control
of Non-Conformities
The laboratory should have a documented procedure for handling non-
conformances and this should address the following:
 Who is authorized and responsible for handling non-conformities.
 What is the immediate action to be defined Damage
Control
 Extent of non-conformity is determined
 Examinations are halted and reports withheld
 Medical significance on the NC is considered
 Results of any NC results already released are recalled
 The responsibility for authorization of resumption of test is defined
4.10: Corrective Action

• CA is the action taken to eliminate the causes of an existing

nonconformity, defect or other undesirable situation in order to
prevent recurrence
• The laboratory shall take corrective action to eliminate the
cause(s) of non-conformities.
• Corrective action shall be appropriate to the effects of the
non-conformities encountered
4.10 Corrective action
• Procedure for CA should state how to:
 review NCs

 Determining root cause of NC

 Evaluating the need for CA to ensure NC does not recur

 Determining and implementing CA needed

 Recording results CA taken

 Reviewing effectiveness of CA taken

4.11 Preventive Actions- what Are they?
• A preventive action is a proactive process for identifying
opportunities for improvement rather than a reaction to the
identification of problems or complaints.
• In addition to the review of operational procedures, preventive
action might involve:
1. Analysis of data, including trend and risk analyses and
2. External Quality assessment
4.11 Preventive actions
• The laboratory shall have a documented procedure for:
a) reviewing laboratory data and information to determine
where potential nonconformities exist;
b) determining the root cause(s) of potential nonconformities;
c) evaluating the need for preventive action to prevent the
occurrence of nonconformities;
d) determining and implementing preventive action needed;
e) recording the results of preventive action taken (see 4.13);
f) reviewing the effectiveness of the preventive action taken.
4.12 Continual Improvement
• The laboratory shall continually improve the effectiveness of the QMS, including the pre-
examination, examination and post-examination processes, through the use of
1. management reviews to compare the laboratory’s actual performance in its
evaluation activities,
2. corrective actions and
3. preventive actions with its intentions, as stated in the quality policy and quality
objectives.
• Improvement activities shall be directed at areas of highest priority based on risk
assessments.
• Action plans for improvement shall be developed, documented and
implemented, as appropriate.
• The effectiveness of the actions taken shall be determined through a focused review or
audit of the area concerned.
• Laboratory management must also communicate to staff improvement plans and goals.
4.13: Control of Records

• A record is a form that has been completed with data about a

certain activity.
• Records can be kept either as hard copy or electronically.
• Consider evaluating back-up activities for records stored
electronically.
• Ensure there is a suitable environment for storage of records
to prevent damage and deterioration from water, fire termites
etc
 4.13: Control of Records
• Amendment of records – date and where relevant the time
and initials of one making amendments. Ensure the original
recorded information visible after cancellation
• Records must be created concurrently with performance of
each activity that affects the quality of the examination.
4.13: Control of Records
• The list of records to be controlled is now a “must” rather than
a “may”. The list also includes additional quality related
records (e.g. supplier selection and performance, minutes of
meetings that record decisions, etc.).
4.13: Control of records
Laboratory should have a records control procedure that covers the
following:
IdentificationHow do you identify that this records to a particular process, section , when
of records and who created it.
Collection how are records created and collected for safe keeping?
Indexing How do you put records in an order , catalogue, filing for easy retrieval of
records
Access What controls are in place for access of records?
Storage Are the storage conditions preventing destruction of records from fire,
water termites etc.
Maintenance How do you ensure that stored records are still in proper condition
Amendment How do we change information on a record
Safe disposal What procedures are in place for safe disposal of records
Managing Records and files
4.14: Evaluation and Audits – Internal
audits in 2007 edition

1. Periodic Review of requests

2. Assessment of user feedback
3. Staff suggestions
4. Internal Audit
5. Risk Management
6. Quality Indicators
7. Review by external organisations
4.14.3 Assessment of user feedback–formally
covered under Resolution of complaints (4.8)

• The laboratory should seek information relating to user perception

as whether the service has met the needs and requirements of
the user.
• This can be done in form of a customer satisfaction survey
or through a feedback meeting.
• Action should be taken when it shows that lab users are not
satisfied with the laboratory service.
• Evidence of improvement is required in the next analysis of the
results.
4.14.4: Staff suggestions
• The laboratory management shall encourage staff to make
suggestions for the improvement of any aspect of the
laboratory service
• Suggestions shall be evaluated, implemented and feedback
provided to staff.
• Actions taken by management as a result of staff suggestions
shall be maintained
4.14.5: Internal Audit
• The laboratory should have a schedule for conducting internal audits at
defined intervals
• The whole quality system should be audited within a one year cycle.
• Areas to be audited should include
 Pre-examination
• Request forms and Primary sample collection manual
• Phlebotomy,
• Transportation of samples to the lab
• Reception
• Storerooms
 Examination
 Post examination
Internal Audits
• Audits should be conducted by personnel trained in internal audits
for both Management and technical requirements.
• Personnel should not audit their own areas of work .
• The audit criteria, scope, frequency and methods should be
defined.
• There are basically three types of audits
vertical, horizontal and witnessing and check if the laboratory is
applying all three tools.
Internal Audits
• In addition to regular internal audits, it may be necessary to
perform special, unscheduled audits. Such audits may be
initiated:
a) as a result of a customer’s complaint which raises doubts about the
laboratory’s compliance with its own policies and procedures;
b) through the detection of an anomalous result (e.g. unacceptable
results in an inter-laboratory comparison);
c) to confirm that corrective actions and other changes of the quality
system have been carried out and are effective.
d) Evaluate the records for special audits especially when you realise
that the laboratory is encountering many challenges and
complaints.
4.14.6 Risk Management
• The laboratory shall evaluate the impact of work processes and
potential failures on examination results as they affect patient
safety, and shall modify processes to reduce or eliminate the
identified risks and document decisions and actions taken
4.14.7 Quality Indicators – formally covered
under Continual improvement (4.12.4)
• Quality Indicators are measured information that:
 Indicates the performance of a process letting you know whether
its in control or not.

 highlights potential quality concerns.

 identifies areas that need further study and investigation, and

 track changes over time.

Developing Quality Indicators
Objective What are you trying to measure?
1. Why am I collecting this information? Be specific
Methodology How to capture the data
1. What data needs to be captured
2. Who (or what) to capture the data
3. How often to capture the data
4. Is it achievable (time, resources, revenue)?
Limits Can I preset levels for:
1. Acceptable, Concern, Unacceptable, Critical
Presentation Graphic or Text
Interpretation 1. What does it mean?
2. Does it reflect on YOUR quality?
3. Can I compare it?
4. Can I trend it?
Action Plan 1. What will I do if it indicates acceptable performance?
2. What will I do if it does not?
Quality Indicators

• Evaluate the effectiveness of implementing quality indicators by

the improvement of the performance of the lab processes over
time.
4.14.8 Reviews by External Organizations –
formally a note under 4.9 – I.D and control of NCs
• When reviews by external organizations indicate the laboratory has
nonconformities or potential nonconformities, the laboratory shall take
appropriate immediate actions and, as appropriate, corrective action or
preventive action to ensure continuing compliance with the QMS and ISO
15189.
• Examples include of external organizations include
• Accreditation bodies assessments
• Regulatory agencies inspections
• Health and safety inspections
• Supervisory assessments:
4.15: Management Review
• A formal evaluation by top management of the status and
adequacy of the quality system in relation to quality policy and
objectives (ISO 8402)
• The quality system shall be systematically and periodically
reviewed to ensure the continued effectiveness of the
arrangements, and any corrective action taken.
• There is need to have a schedule defining the date(s) when
management review is to be done
Management Review input
• At a minimum, the agenda of the management review has to follow what
the standard defines:
 Periodic review of requests, and suitability of procedures
 Assessment of user feedback
 Staff suggestions
 Internal audits
 Risk management
 Use of quality indicators
 Reviews by external organisations
 EQA/PT results
 Monitoring and resolution of complaints
 Performance of suppliers
 Identification and control of NCs
 Results of continual improvement
 Changes in the volume of work
 Recommendations for improvement
Management Review Output
• The output for a management review should be a plan that documents
any decisions made and actions taken during management review.
• Ensure minutes of meetings identify:
• Issues discussed
• Action item to be done
• Responsibility
• Timeline and
• Status
• Findings and actions arising from management reviews shall be recorded
and reported to laboratory staff. Look for the evidence of the
communication.
• Evaluate all the action items and check if they are effectively
completed within the agreed timeline.
Thank you!!